The following data is part of a premarket notification filed by Fujifilm Medical Systems Usa, Inc. with the FDA for Synapse 3d Base Tools.
| Device ID | K120361 |
| 510k Number | K120361 |
| Device Name: | SYNAPSE 3D BASE TOOLS |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM MEDICAL SYSTEMS USA, INC. 419 WEST AVENUE Stamford, CT 06902 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock FUJIFILM MEDICAL SYSTEMS USA, INC. 419 WEST AVENUE Stamford, CT 06902 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-04-06 |
| Summary: | summary |